Summaries for Patients|7 May 2013

Treatment of Idiopathic Pulmonary Fibrosis With Ambrisentan
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What is the problem and what is known about it so far?

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fatal lung disease that causes irreversible scars in both lungs. There are currently no approved treatments for the disease in the United States.

Why did the researchers do this particular study?

In patients with IPF, a cell called a fibroblast proliferates and causes extensive scars that make it harder for oxygen to get into the bloodstream that circulates in the lungs. Ambrisentan is a drug that is known to block some of the biological effects of the fibroblasts; thus, the researchers hoped that it could decrease the formation of further scarring and improve the lung function of patients with IPF.

Who was studied?

Patients with well-defined and well-characterized IPF aged 40 to 80 years who had computed tomography scans that showed minimal or no “honeycombing,” suggesting relatively mild IPF.

How was the study done?

Patients with IPF were randomly assigned to receive either a 10-mg ambrisentan pill or pills that looked exactly the same but did not contain any ambrisentan (placebo pills).

What did the researchers find?

The researchers were surprised and disappointed to find that patients with IPF who received ambrisentan were actually more likely to have their disease worsen and to require hospitalization than those who received placebo.

What were the limitations of the study?

The participants in this study were a subgroup of patients with IPF who do not represent the entire population of patients with IPF. Because the patients who received ambrisentan seemed to be doing worse, the study was stopped earlier than planned; thus, the long-term effects of ambrisentan are unknown.

What are the implications of the study?

Patients with well-defined IPF should not be treated with ambrisentan.

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